Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants
Status:
Completed
Trial end date:
2005-05-01
Target enrollment:
Participant gender:
Summary
It has been observed that in children who get a severe rotavirus infection, subsequent
infections cause either no symptoms or generally only mild or moderate diarrhea. This
evidence is the basis for developing a vaccine since it suggests that the first infection
immunizes the child against disease upon re-infection.
It was found that neonatal avirulent strains 116E and I321 induce protective immunity and
offer clinical protection for at least one year. Both these strains are well characterized
and the safety studies have been done in animal models. These candidate vaccine strains have
been evaluated for safety and immunogenicity in adults and children (2 to 12 years of age) by
a randomized double blind placebo controlled trial in Cincinnati, USA. In India, the
diversity of rotavirus strains is greater and there is greater prevalence of malnutrition and
co-infection with other enteric pathogens. These vaccines have therefore, also been tested in
India.
Phase:
Phase 1
Details
Lead Sponsor:
Society for Applied Studies
Collaborators:
All India Institute of Medical Sciences, New Delhi Centers for Disease Control and Prevention Children's Hospital Medical Center, Cincinnati Indian Institute of Science Ministry of Science and Technology, India National Institutes of Health (NIH) PATH Stanford University